An interventional study of Rescue stenting in Ischemic Stroke, Acute, Stent Stenosis and Thrombosis, sponsored by Can Tho Stroke International Services Hospital. Completed at 1 site in Vietnam. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-12-28.
Sponsored by Can Tho Stroke International Services Hospital · Not applicable, Interventional, and Treatment
Intravenous (IV) recombinant tissue plasminogen activator is the standard of care for patients with acute ischemic stroke (AIS) who present to the hospital within 4.5 hours of symptom onset. However, IV thrombolysis, even bridging thrombolysis (combining intravenous thrombolysis and mechanical thrombectomy) has limited efficacy among patients who had occlusive lesions associated with highgrade arterial stenosis requiring revascularization to improve neurological deficits. The investigators evaluated whether rescue stenting results in good outcomes among patients after the failure of intravenous thrombolysis and bridging thrombolysis.
Stroke is the second most common cause of death worldwide, with an annual mortality rate of approximately 5.5 million. Depending on the timing of presentation, intravenous (IV) administration of recombinant tissue plasminogen activator can be an effective treatment, but is most effective when used between 3 and 4.5 hours of symptom onset. Bridging thrombolysis, which describes the combination of IV thrombolysis and mechanical thrombectomy, can lead to long-term functional independence after 90 days with higher recanalization success rates than IV thrombolysis alone without increased risk. The HERMES meta-analysis of fve trials (MR CLEAN, ESCAPE, REVASCAT, SWIFT PRIME, and EXTEND IA) indicated the potential benefits of mechanical thrombectomy (MT) in case of proximal circulation occlusions. The recanalization failure rate of this treatment, defined as a modified Thrombolysis in Cerebral Ischemia (mTICI) score of 2a or worse, remained high, ranging from 13% to 29%, and most patients experienced poor clinical outcomes. Permanent stent placement has been suggested as a potential approach for achieving successful recanalization, which is the goal of endovascular therapy in the early management of acute ischemic stroke (AIS). However, the risk of intracranial hemorrhage associated with the combined use of IV thrombolysis and a loading dose of dual antiplatelet therapy (DAPT) increases when rescue stenting is applied. The investigators hypothesize that stent deployment might serve as a feasible treatment for large artery occlusion after the failure of intravenous thrombolysis and bridging thrombolysis.
2,612 studies on the registry are indexed under Ischemic Stroke; 971 are open to participants now.
This study's enrollment of 13 is below the median of 120 across 1,776 interventional studies indexed under Ischemic Stroke.
Browse Ischemic Stroke studies →Can Tho Stroke International Services Hospital is the lead sponsor of 8 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Rescue stenting in the severe atherosclerotic stenosis after the failure of intravenous thrombolysis (RESFIT)
Procedure: Rescue stenting
Rescue stenting in the severe atherosclerotic stenosis after the failure of intravenous thrombolysis (RES
The incidence of hemorrhagic transformation
Hemorrhagic transformation was accessed by CT scan or MRI.
Time frame: 24 hours after rescue intracranial stenting.
The rate of good outcomes at 3-month follow-up
The good 3-month outcome rate was accessed by modified Rankin Score (mRS) \< 3.
Time frame: 3 months
Plan to share: No
Ran from May 2020 to primary completion in Aug 2022, 27 months.
Of 572 non-industry interventional studies with no phase under Ischemic Stroke, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 48. This study's 27 months is close to that.
Counting every sponsor, half of 653 studies reached it within 27 months; a quarter within 14 and three quarters within 48.
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This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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Can Tho Stroke International Services Hospital